A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After Hyperthermic Intraperitoneal Chemotherapy (HIPEC)With Oxaliplatin or Mitomycin C in Patients With Primary Appendiceal Tumors.
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15232 |
| Conditions: |
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Peritoneal Cavity Cancer |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and mytomycin C, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Heating a chemotherapy solution and infusing it directly into the
abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor
cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving
oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating
patients with primary colorectal tumors or tumors of the appendix.
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| Study Summary: |
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Primary Objectives: I. To compare the toxicity profiles within 4 weeks of surgery of
oxaliplatin and mitomycin C delivered via intraperitoneal hyperthermic chemoperfusion in
patients with peritoneal surface malignancies from primary colorectal and appendiceal
tumors.
Secondary Objectives: I. To compare the time to progression in patients treated with
oxaliplatin vs. mitomycin C delivered via intraperitoneal hyperthermic chemoperfusion for
surface malignancies from primary colorectal and appendiceal tumors.
OUTLINE: This multicenter, open-label, randomized phase II study. Patients are randomized to
1 of 2 treatment arms. Arm I: Patients undergo surgical cytoreduction and receive mitomycin
C by Hyperthermic Intraperitoneal Chemotherapy(HIPEC).
Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by Hyperthermic
Intraperitoneal Chemotherapy(HIPEC).
After completion of study treatment, patients are followed at 6, 12, 18, 24, 30, and 36
months.
PROJECTED ACCURAL: A total of 116 patients will be accrued for this study.
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| Criteria: |
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Inclusion Criteria:
- Patients must have histologically or cytologically confirmed peritoneal surface
malignancies from primary colorectal and appendiceal tumors
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Please contact study investigator and/or consult protocol document for specific
details on laboratory criteria
- Patients must be recovered from both the acute and late effects of any prior surgery,
radiotherapy, or other antineoplastic therapy
- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or double-barrier method of birth control or abstinence) for the duration
of study participation and for 90 days following Hyperthermic Intraperitoneal
Chemotherapy(HIPEC)
- Ability to understand and the willingness to sign a written informed consent document
(either directly or via a legally authorized representative)
- Participants who have received oxaliplatin during prior systemic chemotherapy
regimens are eligible for enrollment in this protocol
Exclusion Criteria:
- Patients with an active infection or with a fever >= 101.3 F within 3 days of the
first scheduled day of protocol treatment
- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within 30 days of Hyperthermic Intraperitoneal
Chemotherapy(HIPEC) (investigational therapy is defined as treatment for which there
is currently no regulatory authority approved indication)
- Patients with carcinoid tumors
- Patients with active CNS metastases
- Patients with known hypersensitivity to any of the components of oxaliplatin or
mitomycin C
- History of prior malignancy within the past 5 years, except for curatively treated
basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized
prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at
least 3 months apart, with the most recent evaluation no more than 4 weeks prior to
entry
- Patients who received radiotherapy to more than 25% of their bone marrow
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Pregnant/nursing women are excluded from this study because oxaliplatin is an agent
with the potential for teratogenic or abortifacient effects
- Known HIV-, hepatitis B-, or hepatitis C-positive patients (active, previously
treated, or both)
- Peripheral neuropathy >= grade 2
- History of allogenic transplant
- History of prior Hyperthermic Intraperitoneal Chemotherapy(HIPEC)
- Evidence of metastatic disease outside of the abdomen
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| NCT ID: |
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NCT00904267 |
| Primary Contact: |
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Principal Investigator
John H Stewart IV
Wake Forest University
Joyce Fenstermaker, RN
Phone: 336-713-3155
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15232
United States
David L. Bartlett
Phone: 412-692-2852
Email: bartlettdl@msx.upmc.edu
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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